Cleared Traditional

K931626 - CARAPACE STERILE COTTON BALLS (FDA 510(k) Clearance)

Class I General Hospital device.

K931626 · Carapace, Inc. · General Hospital
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Dec 1993
Decision
244d
Days
Class 1
Risk

K931626 is an FDA 510(k) clearance for the CARAPACE STERILE COTTON BALLS. Classified as Fiber, Medical, Absorbent (product code FRL), Class I - General Controls.

Submitted by Carapace, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on December 2, 1993 after a review of 244 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5300 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Carapace, Inc. devices

Submission Details

510(k) Number K931626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1993
Decision Date December 02, 1993
Days to Decision 244 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 128d · This submission: 244d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRL Fiber, Medical, Absorbent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.